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| Sponsor: | Pakistan Institute of Learning and Living |
|---|---|
| Collaborators: |
Karwan e Hayat Dow University of Health Sciences |
| Information provided by: | Pakistan Institute of Learning and Living |
| ClinicalTrials.gov Identifier: | NCT00929955 |
Purpose
There is some evidence that anti-inflammatory treatment may have beneficial effects in schizophrenia and major depression. Cox-2 inhibitors have been tested in preliminary clinical trials for schizophrenia and depression, showing favourable effects compared to placebo (Muller and Schwarz et al 2009).
Statins were introduced as cholesterol-lowering agents but have found much wider usage. They are anti-inflammatory agents and thus similar to the Cox-2 inhibitors, which have shown some ability as adjuncts to improve the symptoms of schizophrenia in preliminary studies. The statins are also known to decrease C-reactive protein (CRP), which has been shown in an SMRI-funded study to be elevated in a study of individuals with schizophrenia. Fan et al (2007) demonstrated in a small study in patients with schizophrenia that higher than normal levels of CRP (>0.50 mg/dl) was associated with marked negative symptoms and higher total PANSS scores.
Ondansetron is a serotonin (5-HT3) receptor antagonist that is generic and widely used to prevent nausea and vomiting in patients receiving chemotherapy for cancer. GSK did a small study on it as an antipsychotic in the 1980s. Since then, several small studies have suggested that it is effective as an adjunct drug in improving the symptoms of schizophrenia.
Statins are widely used in schizophrenia sufferers, particularly those taking second generation antipsychotics, to treat hypercholesterolemia. Both drugs are well tolerated and their side effect profiles well understood.
We propose to conduct a feasibility study in patients with chronic schizophrenia to explore the adjunct use of simvastatin and ondansetron on positive, negative and general psychopathology in comparisons to treatment as usual (TAU) over a 12 week period.
| Condition | Intervention | Phase |
|---|---|---|
|
Schizophrenia Schizoaffective Disorder Psychosis Not Otherwise Specified Schizophreniform Disorder |
Drug: Ondansetron Drug: Simvastatin Drug: Placebo |
Phase I |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single Blind (Investigator) Primary Purpose: Treatment |
| Official Title: | Study of Role of Anti-Inflammatory Agents in Patients With Schizophrenia |
| Estimated Enrollment: | 36 |
| Study Start Date: | June 2009 |
| Estimated Study Completion Date: | September 2009 |
| Estimated Primary Completion Date: | September 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: Ondansetron |
Drug: Ondansetron
ondansetron added to TAU Ondansetron will be administered in 8mg once daily dose
|
| Active Comparator: Simvastatin |
Drug: Simvastatin
Simvastatin added to TAU Simvastatin 20mg taken as once daily dose
|
| Placebo Comparator: Placebo |
Drug: Placebo
Placebo added to TAU
|
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Imran B Chaudhry, MD | +441254226392 | imran.chaudhry@manchester.ac.uk |
| Contact: Nusrat Husain, MD | +441254226392 | nusrat.husain@manchester.ac.uk |
| Pakistan | |
| Karwan e hayat | Recruiting |
| Karachi, Pakistan | |
| Contact: Ajmal Kazmi, MRCPsych +923213783890 kazmiajmal@yahoo.com | |
| Dow University of Health Sciences | Recruiting |
| Karachi, Pakistan | |
| Contact: Raza ur Rahman +923002579364 razaur@yahoo.com | |
| Principal Investigator: | Imran B Chaudhry, MD | University of Manchester |
More Information
| Responsible Party: | Dr Imran B Chaudhry, University of Manchester |
| ClinicalTrials.gov Identifier: | NCT00929955 History of Changes |
| Other Study ID Numbers: | PILL-UoM-0110 |
| Study First Received: | June 28, 2009 |
| Last Updated: | June 29, 2009 |
| Health Authority: | Pakistan: Research Ethics Committee |
|
Anti inflammatory Schizophrenia Simvastatin ondansetron |
|
Mental Disorders Psychotic Disorders Schizophrenia Schizophrenia and Disorders with Psychotic Features Anti-Inflammatory Agents Ondansetron Simvastatin Therapeutic Uses Pharmacologic Actions Antiemetics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Central Nervous System Agents Gastrointestinal Agents |
Antipruritics Dermatologic Agents Serotonin Antagonists Serotonin Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Antipsychotic Agents Tranquilizing Agents Central Nervous System Depressants Psychotropic Drugs Anti-Anxiety Agents Hypolipidemic Agents Antimetabolites Lipid Regulating Agents Hydroxymethylglutaryl-CoA Reductase Inhibitors |